NCT07174609 · Johns Hopkins University
Scrambler Therapy in Chronic Pancreatitis
What this study is about
The investigators will enroll adults with chronic pancreatitis who have persistent abdominal pain not relieved by standard treatments. This study will test the feasibility and effectiveness of Scrambler Therapy, a non-invasive FDA-cleared device that delivers "non-pain" electrical signals through the skin to retrain the brain's pain perception.
View original scientific description
The investigators will enroll adults with chronic pancreatitis who have persistent abdominal pain not relieved by standard treatments. This study will test the feasibility and effectiveness of Scrambler Therapy, a non-invasive FDA-cleared device that delivers "non-pain" electrical signals through the skin to retrain the brain's pain perception. Participants will undergo 5-10 treatment sessions and be followed for 3 months with standardized pain scores and quality-of-life assessments. The goal is to generate pilot data to support larger studies of Scrambler Therapy as a novel option for pancreatic pain.
Interventions
DEVICE
Scrambler Therapy
Adults with chronic pancreatitis and refractory abdominal pain will receive Scrambler Therapy, a non-invasive neuromodulation device. Electrodes are placed near the painful area to deliver "non-pain" signals aimed at reducing pain perception. Participants will complete 5-10 daily treatment sessions, each lasting 30-40 minutes, with pain ratings collected before and after sessions and follow-up assessments over 3 months.
Primary outcome measures
Feasibility as assessed by enrollment rate
Time frame: During recruitment ( expected 24 months)
Number of eligible patients who consent and enroll divided by the total number of eligible patients approached.
Feasibility as assessed by treatment adherence
Time frame: During treatment period (up to 2 weeks)
Number of participants who complete a minimum of 5 Scrambler Therapy sessions out of the planned 5-10, or who discontinue earlier due to achieving adequate pain relief.
Feasibility as assessed by treatment adherence rate
Time frame: During treatment period (average 5-10 days, up to 2 weeks)
Proportion of participants who complete a minimum of 5 Scrambler Therapy sessions out of the planned 5-10, or who discontinue earlier due to achieving adequate pain relief.
Feasibility as assessed by retention
Time frame: Baseline through 3 months post-treatment
Proportion of enrolled participants who complete the 3-month follow-up assessments, including pain ratings.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults aged 18 years and older
- Diagnosis of chronic pancreatitis with refractory abdominal pain
- Able to provide written informed consent in English
- Sufficient English language ability to complete study questionnaires
- Reliable and regular access to a phone for follow-up
Exclusion criteria
- Unable or unwilling to provide written consent
- History or presence of a significant medical or psychiatric condition that would interfere with study participation
- Pregnant or lactating women
- Coronary stents or implanted metallic/electrical devices (pacemaker, defibrillator, aneurysm clips)
- History of epilepsy, traumatic brain injury, or myocardial infarction within the past 6 months
- Skin conditions preventing electrode placement (e.g., open wounds)
- Any condition that, in the investigator's opinion, places the participant at increased risk or prevents full compliance with study procedures
Where
- Baltimore, Maryland
Collaborators
The National Pancreas Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 16, 2025 · Source of record for eligibility and locations